REG - AstraZeneca PLC - Tagrisso approved in Japan for early lung cancer

AstraZenecaAnnouncement

25/08/2022 07:16

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20220825:nRSY1496Xa&default-theme=true

RNS Number : 1496X  AstraZeneca PLC  25 August 2022

25 August 2022 07:05 BST

 

Tagrisso approved in Japan for the adjuvant treatment of

patients with early-stage EGFR-mutated lung cancer

 

Tagrisso is the only EGFR-targeted medicine approved in Japan for the

treatment of early-stage lung cancer after surgery

 

Approval based on results from the ADAURA Phase III trial

 

AstraZeneca's Tagrisso (osimertinib) has been approved in Japan for the
adjuvant treatment of patients with epidermal growth factor receptor-mutated
(EGFRm) non-small cell lung cancer (NSCLC) after surgery. This approval by the
Japanese Ministry of Health, Labour and Welfare was based on positive results
from the global ADAURA Phase III trial.

 

While up to 30% of all patients with NSCLC may be diagnosed early enough to
have surgery with curative intent, recurrence is still common in early-stage
disease.(1,2) Historically, over half of patients diagnosed in Stage II, and
approximately three quarters of patients diagnosed in Stage III, have
experienced recurrence within five years of resection.(3,4) In Japan, lung
cancer is the leading cause of cancer death and among patients with NSCLC,
more than 35% have tumours with an EGFR mutation.(5,6)

 

Masahiro Tsuboi, MD, PhD, Chief and Director, Department of Thoracic Surgery
& Oncology, National Cancer Center Hospital East, Japan, and principal
investigator in the ADAURA trial, said: "Osimertinib was first approved in
Japan over six years ago and it has since played a critical role in our
treatment of patients with lung cancer, particularly given the high prevalence
of EGFR mutations among Japanese patients. This approval of osimertinib for
early-stage lung cancer means these patients will now have, for the first
time, a targeted therapy option available earlier in their treatment journey,
after surgery and chemotherapy as indicated."

 

Dave Fredrickson, Executive Vice President, Oncology Business Unit,
AstraZeneca, said: "Patients diagnosed with lung cancer in Japan are more
likely than patients anywhere else in the world to be alive five years after
their diagnosis. Yet lung cancer remains the country's leading cause of cancer
death. With this approval of Tagrisso, early-stage lung cancer patients in
Japan now have a targeted treatment option available after surgery that can
dramatically change the course of their disease, potentially helping them live
cancer-free even longer."

 

In the ADAURA trial, Tagrisso demonstrated a statistically significant and
clinically meaningful improvement in disease-free survival (DFS) in the
primary analysis population of patients with Stage II and IIIA EGFRm NSCLC.
The trial also showed a statistically significant and clinically meaningful
improvement in DFS in the overall trial population of patients with Stage
IB-IIIA disease, a key secondary endpoint. These results were published in The
New England Journal of Medicine
(https://www.nejm.org/doi/full/10.1056/NEJMoa2027071) in October 2020.

 

The ADAURA trial is ongoing to assess overall survival (OS). Final DFS results
will be presented at the upcoming European Society for Medical Oncology (ESMO)
Congress 2022.

 

Tagrisso is approved to treat early-stage lung cancer in more than 85
countries, including in the US
(https://www.astrazeneca.com/media-centre/press-releases/2020/tagrisso-approved-in-the-us-for-early-lung-cancer.html)
, EU
(https://www.astrazeneca.com/media-centre/press-releases/2021/tagrisso-approved-in-eu-in-early-lung-cancer.html)
and China
(https://www.astrazeneca.com/media-centre/press-releases/2021/tagrisso-approved-in-china-in-early-lung-cancer.html)
, and additional global regulatory reviews are ongoing. In Japan, this is the
third approved indication for Tagrisso following previous approvals for
2nd-line T790M and 1st-line EGFRm NSCLC in March 2016 and August 2018,
respectively.

 

Notes

 

Lung cancer

Lung cancer is the leading cause of cancer death among both men and women,
accounting for about one-fifth of all cancer deaths.(7) Lung cancer is
broadly split into NSCLC and small cell lung cancer, with 80-85% classified as
NSCLC.(8,9) The majority of all NSCLC patients are diagnosed with advanced
disease while approximately 25-30% present with resectable disease at
diagnosis.(1,2)

 

Among patients with resectable tumours (Stage IB-IIIA), the majority of
patients eventually develop recurrence despite complete tumour resection and
adjuvant chemotherapy.(3) In the absence of organised screening efforts,
early-stage lung cancer diagnoses are often only made when the cancer is found
on imaging for an unrelated condition.(10,11)

 

Approximately 30-40% of patients in Asia, and 10-15% of NSCLC patients in the
US and Europe, have EGFRm NSCLC.(12-14) These patients are particularly
sensitive to treatment with an EGFR-tyrosine kinase inhibitor (EGFR-TKI) which
blocks the cell-signaling pathways that drive the growth of tumour cells.(15)

 

ADAURA
ADAURA is a randomised, double-blind, placebo-controlled, global Phase III
trial in the adjuvant treatment of 682 patients with Stage IB, II, IIIA EGFRm
NSCLC following complete tumour resection and, at physicians' and patients'
discretion, adjuvant chemotherapy. Patients were treated with Tagrisso 80mg
once-daily oral tablets or placebo for three years or until disease
recurrence.

 

The trial enrolled in more than 200 centres across more than 20 countries,
including the US, in Europe, South America, Asia and the Middle East. The
primary endpoint was DFS in Stage II and IIIA patients and a key secondary
endpoint was DFS in Stage IB, II and IIIA patients.

 

Though the primary data readout was originally anticipated in 2022, data from
the trial were reported early following a recommendation from an Independent
Data Monitoring Committee (IDMC) based on its determination of overwhelming
efficacy. The trial is ongoing and will continue to assess the secondary
endpoint of OS.

 

Tagrisso
Tagrisso (osimertinib) is a third-generation, irreversible EGFR-TKI with
proven clinical activity in NSCLC, including against central nervous system
metastases. Tagrisso (40mg and 80mg once-daily oral tablets) has been used to
treat more than 600,000 patients across its indications worldwide and
AstraZeneca continues to explore Tagrisso as a treatment for patients across
multiple stages of EGFRm NSCLC.

 

In Phase III trials, Tagrisso is being tested in the neoadjuvant resectable
setting (NeoADAURA), in the Stage IA2-IA3 adjuvant resectable setting
(ADAURA2), in the Stage III locally advanced unresectable setting (LAURA), and
in combination with chemotherapy (FLAURA2). AstraZeneca is also researching
ways to address tumour mechanisms of resistance through the SAVANNAH and
ORCHARD Phase II trials, and the SAFFRON Phase III trial, which test Tagrisso
given concomitantly with savolitinib, an oral, potent and highly selective MET
TKI, as well as other potential new medicines.

 

AstraZeneca in lung cancer

AstraZeneca is working to bring patients with lung cancer closer to cure
through the detection and treatment of early-stage disease, while also pushing
the boundaries of science to improve outcomes in the resistant and advanced
settings. By defining new therapeutic targets and investigating innovative
approaches, the Company aims to match medicines to the patients who can
benefit most.

 

The Company's comprehensive portfolio includes leading lung cancer medicines
and the next wave of innovations, including Tagrisso (osimertinib) and Iressa
(gefitinib); Imfinzi (durvalumab) and tremelimumab; Enhertu (trastuzumab
deruxtecan) and datopotamab deruxtecan in collaboration with Daiichi Sankyo;
Orpathys (savolitinib) in collaboration with HUTCHMED; as well as a pipeline
of potential new medicines and combinations across diverse mechanisms of
action.

 

AstraZeneca is a founding member of the Lung Ambition Alliance, a global
coalition working to accelerate innovation and deliver meaningful improvements
for people with lung cancer, including and beyond treatment.

 

AstraZeneca in oncology

AstraZeneca is leading a revolution in oncology with the ambition to provide
cures for cancer in every form, following the science to understand cancer and
all its complexities to discover, develop and deliver life-changing medicines
to patients.

 

The Company's focus is on some of the most challenging cancers. It is through
persistent innovation that AstraZeneca has built one of the most diverse
portfolios and pipelines in the industry, with the potential to catalyse
changes in the practice of medicine and transform the patient experience.

 

AstraZeneca has the vision to redefine cancer care and, one day, eliminate
cancer as a cause of death.

 

AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical
company that focuses on the discovery, development, and commercialisation of
prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals,
including Cardiovascular, Renal & Metabolism, and Respiratory &
Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries
and its innovative medicines are used by millions of patients worldwide.
Please visit astrazeneca.com (http://www.astrazeneca.com/)  and follow the
Company on Twitter @AstraZeneca (https://twitter.com/AstraZeneca) .

 

Contacts
For details on how to contact the Investor Relations Team, please click here
(https://www.astrazeneca.com/investor-relations.html#Contacts) . For Media
contacts, click here (https://www.astrazeneca.com/media-centre/contacts.html)
.

 

References

1.   Le Chevalier T. Adjuvant Chemotherapy for Resectable Non-Small-Cell
Lung Cancer: Where is it Going? Ann Oncol. 2010;21:196-8.

2.   Cagle P, et al. Lung Cancer Biomarkers: Present Status and Future
Developments. Archives Pathology Lab Med. 2013;137:1191-1198.

3.   Pignon et al. Lung Adjuvant Cisplatin Evaluation: A Pooled Analysis by
the LACE Collaborative Group. J Clin Oncol. 2008;26:3552-3559.

4.  Peters, S. Lungscape: resected non-small-cell lung cancer outcome by
clinical and pathological parameters. Thorac Oncol. 2014;9(11):1675-84.

5.   Sekine I, et al. A Japanese lung cancer registry study on demographics
and treatment modalities in medically treated patients. Cancer Sci.
2020;111(5):1685-1691.

6.   Zhang, Y.L., et al. The prevalence of EGFR mutation in patients with
non-small cell lung cancer: a systematic review and meta-analysis. Oncotarget.
2016; 7(48): 78985-78993.

7.   World Health Organisation. International Agency for Research on Cancer.
Lung Fact Sheet. Available at
https://gco.iarc.fr/today/data/factsheets/cancers/15-Lung-fact-sheet.pdf.
Accessed August 2022.

8.   LUNGevity Foundation. Types of Lung Cancer. Available at
https://lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer.
Accessed August 2022.

9.   Cheema PK, et al. Perspectives on treatment advances for stage III
locally advanced unresectable non-small-cell lung cancer. Curr Oncol.
2019;26(1):37-42.

10.  Sethi S, et al. Incidental Nodule Management - Should There Be a Formal
Process? Journal of Thorac Onc. 2016:8;S494-S497.

11.  LUNGevity Foundation. Screening and Early Detection. Available at
https://lungevity.org/for-patients-caregivers/lung-cancer-101/screening-early-detection.
Accessed August 2022.

12.  Szumera-Ciećkiewicz A, et al. EGFR Mutation Testing on Cytological and
Histological Samples in Non-Small Cell Lung Cancer: a Polish, Single
Institution Study and Systematic Review of European Incidence. Int J Clin Exp
Pathol. 2013:6;2800-12.

13.  Keedy V.L., et al. American Society of Clinical Oncology Provisional
Clinical Opinion: Epidermal Growth Factor Receptor (EGFR) Mutation Testing for
Patients with Advanced Non-Small-Cell Lung Cancer Considering First-Line EGFR
Tyrosine Kinase Inhibitor Therapy. J Clin Oncol. 2011:29;2121-27.

14.  Ellison G, et al. EGFR Mutation Testing in Lung Cancer: a Review of
Available Methods and Their Use for Analysis of Tumour Tissue and Cytology
Samples. J Clin Pathol. 2013:66;79-89.

15.  Cross DA, et al. AZD9291, an Irreversible EGFR TKI, Overcomes
T790M-Mediated Resistance to EGFR Inhibitors in Lung Cancer. Cancer Discov.
2014;4(9):1046-1061.

 

Adrian Kemp

Company Secretary

AstraZeneca PLC

 

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  MSCSEAEELEESEEA